FDA 483 - Triad Rx, Inc - July 21, 2017

An FDA Form 483 was issued following an inspection on July 17, 2017, identifying several deficiencies in aseptic processing and cleanroom operations.

**Facility and Operations:** The inspection observed activities in ISO 5 and ISO 7 classified areas, involving lyophilization and aseptic filling of drug products such as Sermorelin Acetate.

**Violations and Observations:** * **Non-Sterile Wipes:** Cleaning pads/wipes (specifically (b)(4) wipers) used in the ISO 5 area were not sterile. * **Difficult-to-Clean Equipment:** A lyophilizer and portable dehumidifier in the ISO 7 cleanroom, adjacent to ISO 5, were noted as difficult to clean, particle-generating, or visibly dirty. * **Product Exposure:** Drug products intended for lyophilization were (b)(4) in the ISO 5 area, partially stoppered, and then transferred to the ISO 7 lyophilizer via unprotected/uncovered trays, exposing them to air quality lower than ISO 5. * **Glove Contamination:** An operator (initials (b)(6)) performed aseptic processing in the ISO 5 area without consistently disinfecting or changing gloves after touching surfaces or retrieving materials/discarding waste in the ISO 7 area. This affected lots including Sermorelin Acetate 9mg/GHRP-2 9mg Lyophilized, lot 07